Senior Medical Device Risk Engineer

Terumo Neuro; Aliso Viejo (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Terumo Neuro in California is seeking a Staff Engineer, Medical Device Risk to review risk assessments, lead risk analyses, and coordinate cross-functional risk management activities. You will apply risk management principles across R&D, Operations, and Post-Market Surveillance, ensuring compliance with procedures and regulatory requirements.

The role requires 6–8 years of experience in the medical device industry, expertise in ISO 14971, 21 CFR 820, EU MDR, and strong communication skills for

Qualifications

• 6–8 years of experience in medical device industry (Quality Engineering, Product Development, or Manufacturing).
• Experience with ISO 14971, 21 CFR 820, and EU MDR risk management guidelines.
• Ability to translate regulation requirements into practical procedures.
• Ability to lead complex technical projects and write procedures.

Responsibilities

• Evaluate proposed design, process, supplier, and manufacturing changes to assess risk impact and update risk management docs.
• Review risk impact assessments for safety and efficacy implications and benefit-risk analysis.
• Serve as technical lead for cross-functional risk management files, including risk assessments, hazard analyses, and FMEAs.
• Use PHA, FMEA to identify essential requirements and critical quality attributes.
• Facilitate cross-functional risk analysis sessions with Manufacturing, Quality, R&D, Regulatory Affairs, and others.
• Ensure risk management activities and decisions are compliant with procedures and regulatory requirements.
• Drive maintenance and improvement of risk management records aligned with changes and lifecycle activities.
• Provide guidance on proper use of risk criteria and tools to cross-functional partners.
• Support internal audits and regulatory inspections related to medical device risk management.

Skills

Risk assessment

Project leadership

Written & verbal communication

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

Excel

Word

Project

Outlook

Teams

Job description

Terumo Neuro in California is seeking a Staff Engineer, Medical Device Risk to review risk assessments, lead risk analyses, and coordinate cross-functional risk management activities. You will apply risk management principles across R&D, Operations, and Post-Market Surveillance, ensuring compliance with procedures and regulatory requirements.

The role requires 6–8 years of experience in the medical device industry, expertise in ISO 14971, 21 CFR 820, EU MDR, and strong communication skills for